Status:
COMPLETED
Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.
Detailed Description
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have relapsed or refractory non-Hodgkin's lymphoma (NHL). The study looked at anti-tumo...
Eligibility Criteria
Inclusion
- Each participant must meet all of the following inclusion criteria to be enrolled in the study:
- Participant must have histological or cytological diagnosis of a hematological malignancy of the following types that has relapsed or was refractory to prior therapy:
- Diffuse large B-cell lymphoma
- Mantle cell lymphoma
- Burkitt's lymphoma
- Precursor B-lymphoblastic leukemia/lymphoma
- T-cell lymphoma, excluding primary cutaneous T-cell lymphoma
- Transformed follicular lymphoma with ≥ 50% diffuse large cell component.
- Male or female participants 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Measurable disease.
- Exclusion criteria include the following:
- Pregnant or lactating females.
- Known human immunodeficiency virus (HIV) positive or AIDS-related illness.
- Any serious medical or psychiatric illness that could interfere with the completion of treatment.
- Total bilirubin ≥ 1.5 × the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 × the ULN. AST, ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to their underlying hematological disorder.
- Absolute neutrophil count (ANC) \< 1,250/mm\^3.
- Platelet count \< 75,000/mm\^3.
- Calculated creatinine clearance \< 30 mL/minute.
- Autologous stem cell transplant less than 6 months prior to enrollment.
- Participants who have undergone allogeneic stem cell or organ transplantation.
- Systemic antineoplastic therapy including glucocorticoids (\> 15 mg prednisone/day or equivalent), or treatment with an investigational agent within 14 days preceding the first dose of study drug treatment.
- Participants who have received treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment, within 12 weeks prior to first dose.
- Participants who have received treatment with radioimmunoconjugates or within 12 weeks prior to first dose.
- Participants who have received radiotherapy within 21 days prior to first dose.
- Myocardial infarction within 6 months of enrollment or current history of New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
- Major surgery within 14 days prior to the first dose.
- Infection requiring systemic antibiotic therapy within 14 days prior to the first dose or other serious infection.
- Clinically uncontrolled central nervous system (CNS) involvement.
- Inability to swallow capsules.
- History of uncontrolled sleep apnoea syndrome and other conditions that could result in excessive daytime sleepiness (eg, Chronic obstructive pulmonary disease - COPD).
Exclusion
Key Trial Info
Start Date :
February 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00807495
Start Date
February 10 2009
End Date
February 13 2013
Last Update
March 27 2018
Active Locations (1)
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1
Hematology Oncology Associates, Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060